Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage

NCT02149472 | Completed

• 2 other identifiers: NL.46563.058.13P13.246
• Study Type: observational
• Target: 1,649
• Locations: 1 country
• Sites: 1

Brief Summary

Major obstetric haemorrhage (MOH) remains a cause of significant maternal morbidity and mortality worldwide. By identifying women with a higher a priori risk of major haemorrhage during their pregnancy or early during postpartum haemorrhage extra measures to prevent MOH can be taken. In this study the investigators aim to identify haemostatic parameters that during the course of haemorrhage are responsible for the on-going towards major bleeding. By doing this, cut-off points can be defined for future interventions aiming to stop this bleeding process in an early stage. Traditional coagulation parameters are currently not useful for clinical decision making, because of long turn around times. Therefore the added value of available coagulation 'point of care' tests will be evaluated during obstetric haemorrhage.These Point-of-Care (POC) tests could lead to a goal-directed haemostatic therapy for obstetric haemorrhage. A cohort of 9.500 pregnant women will be followed during their pregnancy and delivery. From all women a bleeding score will be obtained during their pregnancy by means of a validated questionnaire. The predictive value of this bleeding score for the occurrence of major obstetric haemorrhage will be evaluated. If postpartum haemorrhage develops (blood loss) \> 1000 cc, blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. The pathway between minor bleeding and major bleeding will be elucidated. Interchangeability and comparability of conventional haemostatic parameters and ROTEM profiles will also be evaluated. The overall goal of the investigators is becoming more able to predict major obstetric haemorrhage in an early stage of postpartum haemorrhage and define thresholds for goal-directed hemostatic therapies.

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Early haemostatic predictors of major obstetric haemorrhage

  During early postpartum haemorrhage changes in hemostatic parameters leading to major obstetric haemorrhage will be identified. Conventional hemostatic parameters and ROTEM profiles will be studied.

  Postpartum haemorrhage within the 24 hrs hours after childbirth

Secondary Outcomes (3)

• Evaluation of ROTEM-based MOH prediction scores as alternative to traditional haemostatic parameters

  Postpartum haemorrhage within first 24 hrs after childbirth

• Incidence of underlying bleeding disorders in patients with MOH

  3 months postpartum

• Predictive value bleeding score in pregnancy for MOH

  Third trimester of pregnancy - 24 hours postpartum

Study Arms (1)

Pregnant women with PPH

All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire during their pregnancy. Only from women developing postpartum haemorrhage \> 1000 cc blood samples will be drawn (n = 600).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women in participating hospitals are asked for their informed consent (n = 9.500). All women will complete a bleeding score generating questionnaire duing their pregnancy. Only from women developing postpartum haemorrhage \> 1000 cc blood samples will be drawn (n = 600) during the course of postpartum haemorrhage for evaluation of changes in haemostatic parameters and ROTEM profiles. 3 months postpartum a nested case cohort study will be performed to compare the incidences of underlying bleeding disorders in the haemorrhage and non-haemorrhage group. This outcome will also be related to the obtained bleeding scores during pregnancy.

You may qualify if:

• \- Pregnancy, gestation age \> 24 weeks

You may not qualify if:

• Age \< 18
• Adults incapable of giving informed consent
• Gestational age \< 24 weeks

Sponsors & Collaborators

• Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research: lead
• Leiden University Medical Center: collaborator
• Erasmus Medical Center: collaborator
• Isala: collaborator

Study Sites (1)

Leiden University Medical Center (LUMC)

Leiden, South Holland, 2300RC, Netherlands

Location

Related Publications (1)

• Tahitu M, Ramler PI, Gillissen A, Caram-Deelder C, Henriquez DDCA, de Maat MPM, Duvekot JJ, Eikenboom J, Bloemenkamp KWM, van den Akker T, van der Bom JG. Clinical value of early assessment of hyperfibrinolysis by rotational thromboelastometry during postpartum hemorrhage for the prediction of severity of bleeding: A multicenter prospective cohort study in the Netherlands. Acta Obstet Gynecol Scand. 2022 Jan;101(1):145-152. doi: 10.1111/aogs.14279. Epub 2021 Nov 3.

  PMID: 34729767 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be drawn for conventional haemostatic parameters and ROTEM profiles. Remaining plasma will be frozen and stored for further evaulation.

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• J G van der Bom, Prof, MD,PhD

  LUMC and Center for Clinical Transufion Research Sanquin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 29, 2014
• Study Start: February 4, 2015
• Primary Completion: April 18, 2018
• Study Completion: April 18, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

NL (1)